(198 days)
Not Found
No
The 510(k) summary describes a mechanical device for IV tubing closure and makes no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is described as providing temporary aseptic closure for IV tubing, maintaining sterility rather than directly treating a medical condition or restoring a bodily function.
No
Explanation: The device is described as providing temporary aseptic closure for IV tubing, which is a functional purpose, not a diagnostic one. It does not analyze patient data or provide medical insights.
No
The device description clearly indicates a physical component ("Swabbable Cap") that provides temporary aseptic closure of a male luer connector. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide temporary aseptic closure of IV tubing connectors. This is a physical barrier function to maintain sterility of the tubing, not a diagnostic test performed on a sample from the body.
- Device Description: The description reinforces the physical closure function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PadLock Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is permanently attached to IV tube sets for general hospital use and is used repeatedly for the life of the administration set.
Product codes
ODI
Device Description
Provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general hospital use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
SECTION 5: 510(k) SUMMARY
| Submitted by: | Baxa Corporation | AUG - 3 2007 | |
|---|---|---|---|
| Contact Person: | Kimberly Zizik | (303) 617-2242 | |
| (303) 690-4204 | |||
| Phone: | |||
| Fax: | |||
| Date Prepared: | |||
| Manufacturing Facility: | Baxa Corporation | ||
| 14445 Grasslands Drive | |||
| Englewood, CO 80112 | |||
| Establishment registration number 1419106 | |||
| Submitted Device: | PadLock™ Swabbable Cap | ||
| Common Name: Set, Intravascular Administration (ODI) | |||
| Product Code: | ODI | ||
| Device Classification: | Class II | ||
| Classification: 21 CFR § 880.5440 Intravascular | |||
| administration set | |||
| (a) Identification . An intravascular administration set is a | |||
| device used to administer fluids from a container to a | |||
| patient's vascular system through a needle or catheter | |||
| inserted into a vein. The device may include the needle or | |||
| catheter, tubing, a flow regulator, a drip chamber, an infusion | |||
| line filter, an I.V. set stopcock, fluid delivery tubing, | |||
| connectors between parts of the set, a side tube with a cap | |||
| to serve as an injection site, and a hollow spike to penetrate | |||
| and connect the tubing to an I.V. bag or other infusion fluid | |||
| container. | |||
| (b) Classification . Class II (performance standards) | |||
| Predicate Device: | Trade Name: Dual Luer Lock Cap | ||
| Common Name: Set, Intravascular Administration | |||
| Classification Name: [880.5440] Intravascular Administration | |||
| Set (Class II) (FPA) | |||
| Manufacturer: Baxter Healthcare Corporation | |||
| 510(k) Number: K981318 | |||
| Product Description: | Provides temporary aseptic closure of the male luer | ||
| connector of the IV tubing while disconnected from the | |||
| patient, replacing the need for disposable caps to maintain | |||
| aseptic procedure. | |||
| Intended Use: | The PadLock Swabbable Cap provides temporary aseptic | ||
| closure of the male luer connector of the IV tubing while | |||
| disconnected from the patient, replacing the need for | |||
| disposable caps to maintain aseptic procedure. The device | |||
| is permanently attached to IV tube sets for general hospital | |||
| use and is used repeatedly for the life of the administration | |||
| set. |
Image /page/0/Picture/3 description: The image shows the word "Baxa" in a bold, sans-serif font. The letters are evenly spaced and the word is centered. The font appears to be a digital font, with a slightly pixelated appearance.
.
Fax
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2007
Ms. Kimberly Zizik Regulatory Assurance Supervisor Baxa, Corporation 14445 Grasslands Drive Englewood, Colorado 80112
Re: K070163
Trade/Device Name: Swabbable Cap Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ODI Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Zizik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Zizik
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Clur
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number: K070163
Device Name: Swabbable Cap
Indications for use:
The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
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K 974163 510(k) Number: __